Advancing Mobility and Socialization in Toddlers With Disabilities: Modified Toy Cars Training With Different Postures

NCT02527356 | Completed

• 1 other identifier: MOST-104-2314-B-182-023-MY3
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The three purposes of this study are: 1) to examine the feasibility and effects of ride-on car training with two different postures on mobility and socialization in toddlers with disabilities; 2) to quantify whether toddlers with disabilities are able to have more exploratory behaviors and social interactions with ride-on car training through observation and wrist-worn accelerators; 3) to determine the critical factors of using the different modes of modified ride-on toy car on family perceptions and participation. The concept of using modified ride-on toy cars (ROC) in therapy has became a novel application in recent years. This study is further to examine the effects of ride-on toy car training with two different postures, i.e., sitting and standing , on independent mobility, exploration and socialization through low-cost, family-centered approach. It will also improve family's understanding of children's capabilities, which improves their development. Based on the power analysis from the preliminary results of investigator group study, investigators will recruit 60 children with disabilities who are between 1 to 3 years old and diagnosed as motor delay. They will be randomly assigned to one of the following three groups: ROC-Sit group, ROC-Stand group and regular therapy group. The whole study duration will be 24 weeks, including 12-week intervention and 12-week follow-up; the total amount of treatment will be equal for three groups. Standardized assessments are provided for a total of three times during the study, including the time before and after the intervention and in the end of the follow-up phase. The ROC-Sit and ROC-Stand programs will be administered by the therapist and include 120 minutes/per session, 2 sessions/per week. The research team will visit the hospital once/per week to provide 60 minutes videotaping and let participants wear wrist-worn accelerators. The regular therapy group will continue their regular therapy without any additional car driving training. The research team will visit them once/per week for the assessments. The assessments include standardized measurements and behavioral coding from the videotapes and accelerators. The findings of this study will provide a novel therapeutic tool (i.e., combining the low-tech modified ride-on cars with different postures) on advancing children's mobility, socialization, family participation and development.

Conditions

Children With Mobility Disabilities

Outcome Measures

Primary Outcomes (4)

• Change from baseline in General Mobility and Social Development at 12 weeks and 24 weeks as assessed by the Pediatric Evaluation of Disability Inventory (PEDI)

  PEDI is a set of tests for children from 8 months to 6 years old. The PEDI quantified self-care, mobility, and social functions. The PEDI is especially useful for tracking changes in functional skills.

  Assessment will occur 3 times during the whole study, including the first and last week of the 12-week intervention, and the end of the 12-week follow-up phase

• Mobility/Driving Performance as assessed by the coding behaviors from the videotaping

  The driving behaviors were coded from each 10-minute Car Play session: a) amount of time moving/total time, b) frequency, time and duration of parental assistance (physical and/or vocal), c) number of successful "directional driving trials". In each of 10 trials, the child is asked to drive 5 feet to the parent or researcher. He/she is given 30 seconds to complete the distance and make a stop at the goal.

  The driving behaviors will be followed for the duration of implementing the intervention and follow-up program at the hospital, an expected average of 24 weeks.

• Socialization as assessed by the coding behaviors from the videotaping

  The frequency and duration related to socialization will be coded during the whole 20-minute Play, including 10-minute Natural Play and 10-minute Car Play: physical contacts, initiation of contact with others, other initiated contacts, facial expressions, vocalizations/gestures and mutual play events (ex. sharing a toy).

  The socialization behaviors will be followed for the duration of implementing the intervention and follow-up program at the hospital, an expected average of 24 weeks.

• Physical Activity for Exploration as assessed by the number of counts recorded from the accelerators wearing on both wrists

  Each week the participant wears the accelerometers on both wrists during the 1 hour videotaping session, including 30-minute driving and 30-minute natural play. The accelerometers code the physical activity for driving and playing. Combining with the results from videotapes, this data enables us to understand the frequency and duration of bimanual use in different activities (i.e., manual exploration).

  The physical activity for exploration behavior will be followed for the duration of implementing the intervention and follow-up program at the hospital, an expected average of 24 weeks.

Secondary Outcomes (6)

• Change from baseline in Body Function/Structure at 12 weeks and 24 weeks as assessed by 5-repetition Sit-to-stand (STS) test

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.

• Change from baseline in General Development at 12 weeks and 24 weeks as assessed by The Bayley Scales of Development

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.

• Change from baseline in General Development at 12 weeks and 24 weeks as assessed by The Affordances in the Home Environment for Motor Development (AHEMD)

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.

• Change from baseline in Participation level at 12 weeks and 24 weeks as assessed by The Goal Attainment Scale (GAS)

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.

• Change from baseline in Parents' Perception at 12 weeks and 24 weeks as assessed by Parenting Stress Index (PSI)

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.

Study Arms (3)

ROC-Stand group

EXPERIMENTAL

The participant's performance is indicative of the extent to which early power mobility training is feasible for 1 to 3 years old and diagnosed as motor delay (\>1.5 sd). Parents/caregivers and occupational therapists will be responsible for ride-on car with standing posture training (ROC-stand).

Behavioral: Ride-On Cars with Standing Posture (ROC-Stand)

ROC-Sit group

ACTIVE COMPARATOR

The participant's performance is indicative of the extent to which early power mobility training is feasible for 1 to 3 years old and diagnosed as motor delay (\>1.5 sd). Parents/caregivers and occupational therapists will be responsible for ride-on car with standing posture training (ROC-sit)

Behavioral: Ride-On Cars with Standing Postures (ROC-Sit)

Regular Therapy group

ACTIVE COMPARATOR

The participant's performance is indicative of the extent to which early power mobility training is feasible for 1 to 3 years old and diagnosed as motor delay (\>1.5 sd). Parents/caregivers and occupational therapists will be responsible for regular therapy.

Behavioral: Regular Therapy Program

Interventions

Ride-On Cars with Standing Posture (ROC-Stand) BEHAVIORAL

The 2-hour training session is composed of two 30-minute driving sessions and two 25-minute natural play sessions, with a 10-minute break. Every week's treatment program will be before planned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Training will concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving in a hospital, and upper limb use in functional tasks with driving and hand use in functional tasks for exploration in natural play session.

ROC-Stand group

Ride-On Cars with Standing Postures (ROC-Sit) BEHAVIORAL

Most of the guidelines are similar with ROC-Stand, except for the posture of driving. The training time and period is the same as ROC-Stand. The two 30-minute driving sessions can also be divided into 4 times of 15-minute sessions, depending on the child's standing ability with supported condition.

ROC-Sit group

Regular Therapy Program BEHAVIORAL

The research team will ask caregivers to identify goals (before intervention), and measure progress using goal-attainment scaling (GAS). The regular therapy group will continue the regular therapy, including physical, occupational and speech therapy. In addition, they will receive training program in a hospital for 2 hours/per session, 2 sessions/per week for a total of 12-week intervention. The participants will also experience the two 30-minute car driving sessions during the whole 2-hour training. The difference between the regular therapy group and the two ROC groups is the experience of car driving is controlled by the therapist, i.e. passive locomotion. The general propose of the training is to improve the developmental scales, mobility, socialization and upper limb use in functional tasks. The research team will videotape the child's natural play and driving performance for 1 hour/per session, 1 session/per week during the 12-week intervention phase.

Regular Therapy group

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Motor delays resulting in motor impairments that prevented independent walking (standard deviation (SD) \< -1.5, assessed by the Chinese Child Development Inventory (CCDI) via a pediatric physician) )
• Able to stand independently for 2 seconds or to tolerate standing with support for 10 minutes
• Able to reach the objects with either one or two hands
• The height is between 69 to 103 cm and the weight is between 7-18 kg
• Consent of the parents to agree to the testing procedures and participate in the training program

You may not qualify if:

• Children with severe sensory impairments such as blindness, deafness
• The height is not between 69 to 103 cm and the weight is not between 7 to 18 kg
• Parents/caregivers are not able to make a time commitment for the training phase.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 33302, Taiwan

Location

Related Publications (2)

• Huang HH, Lee YT, Lai CL, Lin MC. On-time power mobility and physical activity in toddlers with motor delays: A randomized controlled trial using body-worn sensors. Assist Technol. 2025 Mar 4;37(2):111-119. doi: 10.1080/10400435.2024.2423606. Epub 2024 Nov 7.

  PMID: 39508783 DERIVED

• Huang HH, Tsai WY, Lin YN, Hung CY, Chan AT. Caregivers' Perceptions of Ride-On Cars and Behavioral Changes for Young Children With Motor Delays. Pediatr Phys Ther. 2024 Jan 1;36(1):42-51. doi: 10.1097/PEP.0000000000001066. Epub 2023 Oct 11.

  PMID: 37820358 DERIVED

Study Officials

• HsiangHan Huang, ScD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 19, 2015
• Study Start: November 5, 2015
• Primary Completion: July 31, 2019
• Study Completion: October 31, 2019
• Last Updated: July 10, 2020

Record last verified: 2019-07

Locations

TW (1)